South Ko­re­an reg­u­la­tor sus­pends Sam­sung Bi­o­Log­ic­s' stock, cit­ing ac­count­ing vi­o­la­tions

Sam­sung’s biotech arm Sam­sung Bi­o­Log­ics in­flat­ed its val­ue ahead of its 2016 list­ing, will­ful­ly breach­ing ac­count­ing stan­dards, South Ko­rea’s fi­nan­cial reg­u­la­tor has found, cap­ping months of spec­u­la­tion sur­round­ing the com­pa­ny’s ac­count­ing prac­tices, ac­cord­ing to re­ports pub­lished on Wednes­day.

South Ko­rea’s Se­cu­ri­ties and Fu­tures Com­mis­sion (SFC) has sus­pend­ed Bi­o­Log­ics’ stock, fined the firm 8 bil­lion won ($7.04 mil­lion), and has tasked the stock mar­ket op­er­a­tor — the Ko­rea Ex­change — to re­view whether Sam­sung Bi­o­Log­ics should be delist­ed al­to­geth­er, ac­cord­ing to Nikkei.

The news like­ly pos­es a sig­nif­i­cant hur­dle for the tech gi­ant that is mak­ing a sig­nif­i­cant in­vest­ment in health to rein­vig­o­rate its growth en­gine. Af­ter build­ing up a biosim­i­lars group and branch­ing out in­to new drug de­vel­op­ment, Sam­sung in Au­gust an­nounced plans to make a big push on the bio­phar­ma­ceu­ti­cals front over the next three years.

South Ko­re­an reg­u­la­tors have been in­ves­ti­gat­ing al­le­ga­tions that the Bi­o­Log­ics unit of the fam­i­ly-run con­glom­er­ate vi­o­lat­ed ac­count­ing rules by amend­ing the val­u­a­tion method of its stake in a joint ven­ture – Sam­sung Bioepis – in 2015 to in­flate prof­it be­fore list­ing a year lat­er. Kim Yong-beom, vice chair­man of the com­mis­sion, has ad­vised the firm to dis­miss its chief ex­ec­u­tive, Reuters re­port­ed.

Sam­sung has de­nied any wrong­do­ing and said it plans to chal­lenge the rul­ing. In a state­ment to Bio­Process In­sid­er, Sam­sung Bi­o­Log­ics “apol­o­gized to its clients and share­hold­ers for the con­fu­sion caused by the re­cent ac­count­ing is­sue” and stressed that no ac­coun­tan­cy rules had been breached.

The SFC de­ci­sion has al­so im­pact­ed the Bi­o­Log­ics’ au­di­tors — De­loitte An­jin and KP­MG Samjung — that have been banned from au­dit­ing the com­pa­ny for three and five years re­spec­tive­ly, ac­cord­ing to the Nikkei re­port.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Fol­low­ing US, Chi­na hos­pi­tal ef­forts, Gilead plots its own PhI­II tri­als for close­ly watched Covid-19 drug

Gilead is launching its own Phase III trials of remdesivir, the repurposed antiviral that a WHO official called the “one drug right now we think may have real efficacy” against Covid-19 as the novel coronavirus originating from Wuhan, China ravages the world.

Announced just a day after the NIH and the University of Nebraska Medical Center registered their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March. They will recruit primarily in Asian countries but will also include patients from other locations with “high numbers of diagnosed cases,” the company said.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.

Clin­i­cal tri­al spon­sors have to dis­close decade’s worth of un­re­leased da­ta, fed­er­al judge rules

A decade’s worth of unreleased trial data may soon see the light of day.

A New York federal judge ruled this week that the FDA and the NIH have for years misinterpreted a law that would require companies, universities and other clinical trial sponsors to release trial data from studies completed between 2007 and 2017. The ruling covers drugs and medical devices that were experimental when the study was completed but have since been approved, potentially putting hundreds of sponsors out of compliance if they don’t put their results on clinicaltrials.gov.